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ADMP

Adamis Pharmaceuticals

$0.73

-0.0021 (-0.29%)

20:04
11/04/19
11/04
20:04
11/04/19
20:04

Adamis Pharmaceuticals says yet to receive FDA response on its ZIMHI injection

Adamis Pharmaceuticals announced that as of the close of business today, Adamis has not received any notice of action from the FDA on the company's New Drug Application relating to its ZIMHI high-dose naloxone injection product for the treatment of opioid overdose. As Adamis has previously stated, in connection with its acceptance for review of the NDA the FDA previously provided a PDUFA target agency action date of October 31, 2019. However, the FDA's review processes can extend beyond, and in some cases significantly beyond, anticipated or target completion or action dates due to the timing of the FDA's review process, FDA requests for additional data, information, materials or clarification, difficulties scheduling an advisory committee meeting, FDA workload issues, extensions resulting from the submission of additional information or clarification regarding information already in the submission, or other reasons. Adamis intends to make an announcement relating to FDA action concerning the NDA after it receives a notice of action or similar communication from the agency.

ADMP Adamis Pharmaceuticals
$0.73

-0.0021 (-0.29%)

07/16/19
RILY
07/16/19
DOWNGRADE
Target $1.1
RILY
Sell
Adamis Pharmaceuticals downgraded to Sell from Neutral at B. Riley FBR
B. Riley FBR analyst Andrew D'Silva downgraded Adamis Pharmaceuticals to Sell from Neutral and lowered his price target for the shares to $1.10 from $1.90.
07/16/19
RILY
07/16/19
DOWNGRADE
Target $1.1
RILY
Sell
B. Riley FBR downgrades Adamis to Sell, cuts price target to $1.10
B. Riley FBR analyst Andrew D'Silva downgraded Adamis Pharmaceuticals to Sell from Neutral and lowered his price target for the shares to $1.10 from $1.90. Despite recent injectable epinephrine shortages, channel checks indicate nominal penetration of Symjepi across the retail market and the institutional setting, which is where Sandoz initially launched Symjepi, D'Silva tells investors in a research note. Further, the analyst believes these issues will likely be exacerbated by AUVI-q's growing presence at Walgreens and the expiration date being extended for the EpiPen. In addition, D'Silva continues to believe Adamis will likely need a "significant" capital infusion this year to sustain operations.
07/23/19
RILY
07/23/19
UPGRADE
RILY
Neutral
Adamis Pharmaceuticals upgraded to Neutral from Sell at B. Riley FBR
07/23/19
RILY
07/23/19
UPGRADE
Target $1.1
RILY
Neutral
B. Riley FBR upgrades Adamis to Neutral, keeps $1.10 price target
As previously reported, B. Riley FBR analyst Andrew D'Silva upgraded Adamis Pharmaceuticals (ADMP) to Neutral from Sell after the stock declined to his $1.10 price target, which he maintains. He continues to worry that the PDUFA date for its naloxone candidate could be delayed and expects a slower than initially expected ramp up for its EpiPen alternative that is marketed by Novartis' (NVS) Sandoz unit, D'Silva tells investors.

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